Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

NCT ID: NCT02589288

Last Updated: 2017-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-03-31

Brief Summary

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The aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.

Detailed Description

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Conditions

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Injury of Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Continuous Infusion

Patients receive a postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Group Type ACTIVE_COMPARATOR

Continuous Infusion of ropivacaine 0.2%

Intervention Type PROCEDURE

Postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Automatic Intermittent Bolus

Patients receive a postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% and 4 ml PCA bolus, lockout 20 minutes every hour via electronic infusion pump (Micrel device, Greece).

Group Type EXPERIMENTAL

Automatic Intermittent Bolus of ropivacaine 0.2%

Intervention Type PROCEDURE

Postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% every hour and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Interventions

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Continuous Infusion of ropivacaine 0.2%

Postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Intervention Type PROCEDURE

Automatic Intermittent Bolus of ropivacaine 0.2%

Postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% every hour and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Intervention Type PROCEDURE

Other Intervention Names

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naropine 0.2%

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years old
* American society of anesthesiology (ASA) physical status I-II
* Signed informed consensus

Exclusion Criteria

* ASA \>II
* Unstable neurological disease
* Diabetic mellitus (DM) type I-II
* Allergy to used drugs
* Opioid chronic treatment
* Consensus refusal or not valid
* Anticoagulant therapy
* Postoperative intensive care required
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Gaetano Pini-CTO

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Cappelleri

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluca Cappelleri, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Istituto ortopedico Gaetano Pini

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IOGPGC09

Identifier Type: -

Identifier Source: org_study_id

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